"Dr. Clark Store" Turmeric Powder 1 Cup, Item # 10196-1; Product is a bright yellow granulated powder packaged in a clear flexible plastic ziplock-like bag. The product is a dietary supplement. Label on the product does not indicate intended use.; Product label reads in part: "Dr. Clark Store *** Potent & Pure without excipients *** Dietary Supplement *** Turmeric Powder *** 1 Cup *** Suggested Use: Persons 12 or more years of age take up to 1/4 tsp 3 times daily or as directed by a health professional. Expect yellow stool. *** Warning: If you are pregnant/lactating or have any history of liver, gall-bladder or gastrointestinal problems, please consult a Healthcare Professional prior to use. Recall # F-1827-2011

1) "Dr. Clark Purity Products" Turmeric Dietary Supplement, Item # 10349-100, 500mg, 100 Capsule bottle; Product is packaged in a white rigid plastic bottle. Label background is of a light gray color. The capsules are clear colorless gelatin capsules. When the Turmeric is encapsulated, the capsule appears yellow.; Product label reads in part: "Turmeric *** Dietary Supplement *** 500mg *** 100 capsules *** Directions: Adults take up to 2 capsules 3 times a day with meals, or as directed by a health professional. Children, 12 and over, take 1 capsule up to 3 times per day with meals, or as directed by a health professional. *** Expect yellow colored stool. *** Keep out of reach of children. *** Store at room temperature *** Supplement Facts *** Serving Size: 2 Capsules ***Serving per container: 50 *** Other ingredients: Easy to swallow gelatin capsules. Does not contain tablet binders, coatings or colorings. Recall # F-1828-2011;

2) "Dr. Clark Store Potent & Pure without excipients" Turmeric, Item #10349-100, 500mg, 100 Capsules bottle; Product is packaged in a white rigid plastic bottle. Label background is of a bright yellow color. The capsules are clear colorless gelatin capsules. When the Turmeric is encapsulated, the capsule appears yellow.; Product label reads in part: "Dr. Clark Store *** Potent & Pure without excipients *** Dietary Supplement *** Turmeric *** 500mg *** 100 Capsules *** Suggested use: Persons 12 yore more years of age, take up to 2 capsules 3 times daily or as directed by a health professional. Expect yellow stool. *** This is a whole, fresh, natural ground herb in its purest form. No extraction or chemical process applied. Helps to support a healthy inflammatory response. Warning: If you are pregnant/lactating or have any history of liver, gall bladder or gastrointestinal problems, please consult a Health Professional prior to use. Store this product dry and cool. Keep out of reach of children. Disclaimers: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat a cure, or prevent any disease. Company doesn't adopt any Dr. Clark claims. Supplement Facts *** Serving Size: 2 Capsules *** Servings per container: 50. Recall # F-1829-2011;

The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.

Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, a appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product unapproved new drugs.

When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240: Door open/Switching tube/X-ray lock" will appear.

The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.

VOLUME OF PRODUCT IN COMMERCE

6,269 units

DISTRIBUTION

Nationwide and Internationally

___________________________________

PRODUCT

The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use. Part 00-6202-052-21. Recall # Z-3279-2011

Product may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. There has been one reported incident where the surgeon was unable to lock the liner into the shell because the locking ring groove was too shallow. Investigation revealed that there may be other shells from the same part/lot combination that have the same manufacturing non conformance.

The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. This scenario would result in instability of the product and poses the potential for serious injury to the user in the event of a fall.

GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.

A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message